Journal
CLINICAL CANCER RESEARCH
Volume 26, Issue 15, Pages 3969-3978Publisher
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-19-1997
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Funding
- NIH/NCI [CA180888, CA180819, CA180820, CA180821, CA180830, CA189821, CA189971, CA180826, CA189830, CA180858, CA189858, CA189872, CA189829, CA180846, CA139519, CA189822, CA180798, CA189808, CA189952, CA46282, CA13612]
- Onyx Pharmaceuticals, Inc.
- National Cancer Institute [R01 CA194264, R01 CA184464]
- Leukemia & Lymphoma Society [SCOR-12206-17]
- Dr. Miriam and Sheldon G. Adelson Medical Research Foundation
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Purpose: Treatment of multiple myeloma has evolved tremendously and optimal utilization of available therapies will ensure maximal patient benefits. Patients and Methods: We report the Southwest Oncology Group randomized phase II trial (S1304) comparing twice weekly low-dose (27 mg/m(2); arm 1) to high-dose carfilzomib (56 mg/m(2); arm 2), both with dexamethasone, administered for 12 cycles (11 months) for relapsed and/or refractory multiple myeloma with up to six prior lines of therapy (NCT01903811). The primary endpoint was progression-free survival (PFS), and patients on arm 1 could cross-over to arm 2 after progression on treatment. Results: Among 143 enrolled patients, of whom 121 were eligible and analyzable, the overall response rate was 42.8%, with no significant difference between the arms (P = 0.113). Also, neither the median PFS [5 months and 8 months, respectively; HR, 1.061; 80% Wald confidence interval (CI), 0.821-1.370; P = 0.384] nor the median overall survival were significantly different (26 and 22 months, respectively; HR, 1.149, 80% Wald CI, 0.841-.571; P = 0.284). Sixteen patients crossed over to arm 2 with a median PFS benefit of 3 months. Certain adverse events (AE) were more frequent in arm 2, including fatigue, thrombocytopenia, and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs. Conclusions: This randomized trial did not support a benefit of fixed duration, twice weekly 56 mg/m2 dosing of carfilzomib over the 27 mg/m(2) dose for the treatment of relapsed and/or refractory multiple myeloma. However, treatment to progression in earlier patient populations with high-dose carfilzomib using different schedules should still be considered as part of the standard of care.
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